2021
Emergency Use Listing Procedure for vaccines
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
The procedure is a key tool for companies wishing to submit their products for use during health emergencies.
Eligibility of candidate products
For vaccines to be eligible under the EUL procedure the following criteria must be met:
- The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children);
- Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);
- The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs; and
- The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.
Evaluation procedure
Evaluation will determine whether, in light of available WHO/international standards, the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety and effectiveness are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.
Application for an EUL
The submission for EUL of a vaccine should follow the ICH common technical document (CTD) format. The vaccine manufacturer must apply to WHO with the following information:
- manufacturing quality data
- non-clinical data and clinical data
- a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
- labelling details.
SOURCE: WHO
